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Edited Transcript of ALCLS.PA earnings conference call or presentation 6-Aug-20 11:30am GMT

·46 mins read

Q2 2020 Cellectis SA Earnings Call Romainville Sep 15, 2020 (Thomson StreetEvents) -- Edited Transcript of Cellectis SA earnings conference call or presentation Thursday, August 6, 2020 at 11:30:00am GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * André Choulika Cellectis S.A. - Co-Founder, Chairman & CEO * Carrie Brownstein Cellectis S.A. - Chief Medical Officer * Eric Dutang Cellectis S.A. - CFO * Simon Harnest Cellectis S.A. - VP of Corporate Strategy & Finance ================================================================================ Conference Call Participants ================================================================================ * Biren N. Amin Jefferies LLC, Research Division - MD and Senior Equity Research Analyst * Hartaj Singh Oppenheimer & Co. Inc., Research Division - Research Analyst * Huidong Wang Barclays Bank PLC, Research Division - Research Analyst * James William Birchenough Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst * Michael Werner Schmidt Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD * Salveen Jaswal Richter Goldman Sachs Group, Inc., Research Division - VP * Samantha Corwin William Blair & Company L.L.C., Research Division - Associate * Samantha Lynn Semenkow Citigroup Inc., Research Division - Senior Associate * Wangzhi Li Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Greetings, and welcome to the Cellectis Second Quarter Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Simon Harnest. Thank you. You may begin. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [2] -------------------------------------------------------------------------------- Thank you, and welcome, everyone, to Cellectis Second Quarter 2020 Corporate Update and Financial Results Conference Call. Joining me on the call today with prepared remarks are Dr. André Choulika, our Chairman and Chief Executive Officer; Dr. Carrie Brownstein, our Chief Medical Officer; and Eric Dutang, our Chief Financial Officer. Yesterday evening, Cellectis issued a press release reporting our financial results for the second quarter ended June 30, 2020. The press release is available on our website at cellectis.com. As a quick reminder, we will make forward-looking statements regarding financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F on file with the SEC and the financial report, including the management report for the year ended December 31, 2019, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to André. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [3] -------------------------------------------------------------------------------- Thank you, Simon. Good morning, and thank you, everyone, for joining us today. I will start with a quick introduction before handing the call over to our Chief Medical Officer, Carrie Brownstein, for an update on our clinical programs; and our Chief Financial Officer, Eric Dutang, for a review of the financials. The second quarter of 2020 has been very productive for Cellectis. We continue to be amazed by the commitment and the relentlessness of every nurse and doctor who gives outstanding care to cancer patients at the critical need in these exceptional times. I would like to highlight the outstanding progress our partners, Allogene and Servier, have made in driving forward for the development of our lead license candidates, UCART19 and UCARTBCMA, which Allogene renamed into ALLO-501, ALLO-501A and ALLO-715, respectively. As a reminder, UCART19 or ALLO-501 is exclusively licensed to Servier, and Servier exclusively sublicensed its right in the U.S. to Allogene. UCARTBCMA or ALLO-715 is exclusively licensed to Allogene. ALLO-501 has made headlines at ASCO in June where our partners, Allogene and Servier, presented interim Phase I dose escalation data in patients with non-Hodgkin's lymphoma with a complete response rate of 44% and an overall response rate of 75% in the subgroup of patients who were naïve to CAR T-cell treatment. No GvHD, an adequate safety profile, this data update comes as a follow-up to the data presented at ASH 2018 where the Phase I dose escalation in relapsed/refractory ALL patients showed an 82% CR rate at an optimal lymphodepletion. UCARTBCMA or ALLO-715 is also progressing nicely into Phase I dose escalation trial in relapsed/refractory multiple myeloma patients. The advancement of our partner program significantly de-risk the anticipated milestone and royalty revenue for Cellectis. Cellectis is entitled to receive up to $410 million in outstanding milestones payment plus a low double-digit royalty on a worldwide sale from Servier and Allogene for the CD19-directed allogeneic-CAR-T program as well as up to $2.8 billion in milestone payment plus a high single-digit royalty on worldwide sales from Allogene directly for the 15 licensed allogeneic CAR T-cell targets, including BCMA. On our side, we are pleased to see the progress in patient enrollment for our proprietary allogeneic CAR T-cell program for UCART22 for patient with relapsed/refractory BLL in the BALLI-01 trial as well as UCART123 for patients with relapsed/refractory AML in the AMELI-01 trial. Both programs are currently at dose level 2 in their respective Phase I dose escalation after dosing their first patient in December and January, respectively. UCARTCS1 for patients with relapsed/refractory multiple myeloma in the MELANI-01 trial has been put on hold early July, following the death of a patient at DL2. And we're currently working with the FDA to address the agency's request and hope to resume the trial. Our strategy is to give an early interim data update on one of our proprietary program in Q4 for this year at around a relevant scientific meeting. This update will be the beginning of our proprietary clinical data readout, which we plan to give on periodically at relevant scientific meeting in regular intervals. With that, I would like to hand the call over to Dr. Brownstein, our Chief Medical Officer, to discuss the status of Cellectis-sponsored trial. Carrie, please go ahead. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [4] -------------------------------------------------------------------------------- Thank you, André. As previously mentioned, BALLI-01 evaluating UCART22 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia and AMELI-01 evaluating UCART123 in patients with relapsed/refractory acute myelogenous leukemia continue to progress through their respective dose levels in these Phase I dose escalation studies. The primary objective of these Phase I studies is to evaluate the safety of the product candidates and determine an optimal UCART dose and corresponding lymphodepletion regimen. In addition to safety, correlative studies will evaluate T-cell expansion, window of persistence and antitumor activity at all dose levels. As a reminder, BALLI-01 is planned to complete 3 consecutive dose cohorts, and AMELI-01 is planned to complete 4 consecutive dose cohorts, followed by expansion cohorts at the optimal dose and lymphodepletion regimen. The optimal lymphodepletion regimen prior to the administration of allogeneic CAR T-cell product candidates remains an area of investigation in the field of CAR T-cell therapy. One of the fundamental goals of our Phase I dose escalation and expansion trials is to determine the optimal lymphodepletion regimen prior to treatment with the allogeneic CAR T-cell product. Cellectis is the patent holder and inventor of the CD52 knockout in allogeneic CAR T-cells that allows the use of a CD52-targeting antibody like alemtuzumab in the lymphodepletion strategy. This concept has demonstrated a prolonged selective host T-cell depletion, which correlated with allo-CAR-T expansion and is already incorporated in the current UCART19, UCART22 and UCART123 constructs. We recently filed protocol amendments with the FDA for both the BALLI-01 trial with UCART22 and AMELI-01 trial with UCART123 to include the evaluation of the addition of alemtuzumab to the cyclophosphamide plus fludarabine lymphodepletion regimen. Importantly, this UCART22 program also allows the enrollment of patients who have previously failed prior anti-CD19 CAR T-cell therapies, giving these patients with significant unmet medical need another CAR T-cell therapy option. UCART123 is currently in dose level 2 in patients with relapsed or refractory AML. To date, the AMELI-01 study is advancing as planned, and importantly, we have not seen any adverse safety signals in the Phase I dose escalation. Moving on to UCARTCS1. On July 6, 2020, Cellectis announced that the MELANI-01 trial Phase I dose escalation and expansion study of UCARTCS1 in patients with relapsed and refractory multiple myeloma had been placed on clinical hold by the FDA. This hold, which impacts only this specific product candidate, was initiated following the submission of a safety report regarding one patient enrolled in the study at dose level 2. The patient who had been treated unsuccessfully with numerous lines of prior therapy, including autologous CAR T-cells, experienced a fatal treatment-emergent adverse event toward the end of the 28-day DLT observation period. Clinical evaluation of the case is ongoing, and additional details as to the immediate and underlying causes of this event are being collected. Of note, prior to the clinical hold being issued by the FDA, we had already decided to expand enrollment at dose level 1, which may be an appropriate dose for further evaluation in the expansion portion of this trial and potentially the recommended Phase II dose based on assessment of the preliminary clinical and translational data. We had already begun executing updates to the clinical protocol to reflect this and as well as to monitor and mitigate for potential risks, given the novel mechanism of action of UCARTCS1 product candidate. We are working closely with the FDA to address the agency's request. Additional information and an amended protocol are expected to be submitted in due course as we are working diligently with the agency towards lifting the hold in order to advance this promising program in the clinic. With that, I would like to hand over the call to our Chief Financial Officer, Eric Dutang, for an overview of our first quarter 2020 financials. Eric? -------------------------------------------------------------------------------- Eric Dutang, Cellectis S.A. - CFO [5] -------------------------------------------------------------------------------- Thank you, Carrie. Cellectis first half 2020 was driven by strong financials. The cash, cash equivalents, current financial assets and restricted cash position of Cellectis stand-alone without Calyxt as of June 30, 2020, was at $282 million compared to $304 million as of December 31, 2019. That reflects $28 million of proceeds received from Servier in connection with the March 2020 amendment to the License, Development and Commercialization Agreement, which was offset by $48 million of net cash flows used in operating, investing and lease financing activity and $3 million of unfavorable Forex impact. This cash position will be sufficient to fund Cellectis stand-alone operation into 2022. The consolidated cash, cash equivalents, current financial assets and restricted cash position of Cellectis, including Calyxt, was $317 million as of June 30, 2020, compared to $364 million as of December 31, 2019. The change notably reflects $20 million and $26 million of net cash flows used in operating capital expenditures and lease financing activities of Cellectis and Calyxt, respectively. The Cellectis stand-alone net income attributable to shareholders of Cellectis was $3 million in the first half of 2020 compared to a net loss of $37 million in the first half of 2019. This $40 million increase in the net result between 2020 and 2019 was primarily driven by a significant increase in revenues and other income of $46 million and a decrease in SG&A expenses of $1 million. That was partially offset by an increase in R&D expenses of $4 million and a decrease in financial gains of $4 million. The consolidated net loss attributable to shareholders of Cellectis, including Calyxt, was $12 million or $0.29 per share in the first half of 2020 compared to $49 million or $1.50 per share in the first half of 2019. The consolidated adjusted net loss attributable to shareholders of Cellectis, excluding noncash stock-based compensation expenses, was $4 million or $0.09 per share in the first half of 2020 compared to $39 million or $0.91 per share in the first half of 2019. We are laser-focused to spend our cash at developing our deep pipeline of product candidates in the clinic and completing the construction of our state-of-the-art manufacturing facilities in Paris and in Raleigh in 2020. I will now turn the presentation back over to André for closing remarks. André? -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [6] -------------------------------------------------------------------------------- Thank you, Eric. We continue to invest our human capital, and a big part of this is the growth of our in-house manufacturing platform. I'm excited to announce that Dr. Steve Doares recently joined Cellectis from Biogen as Senior Vice President of our U.S. manufacturing site and head of our Raleigh manufacturing plant in North Carolina. At Biogen, Steve led all aspects of global manufacturing sciences, technology transfer and manufacturing process support. We're all looking forward to see his leadership and guidance advance our mission to develop life-changing allogeneic cure CAR T-cell product for cancer patients. Dr. Leopold Bertea joined us in May 2020 in the role of Senior Vice President of Technical Operations, Europe. His mission is to ensure execution at the GMP Paris manufacturing facility with support to the development and production of Cellectis proprietary product candidate. Dr. Bertea joined Cellectis from CellforCure where he was General Manager and Site Head through the acquisition of CellforCure by Novartis. Dr. Bertea and Dr. Doares will be jointly leading Cellectis' technical operation, replacing Bill Monteith, who is leaving the company on August 6, 2020, to pursue other opportunities. Both are joining the company executive committee. We're on track to complete our full manufacturing independence by mid of next year, which will be an important piece of further establish Cellectis as a leader in the allogeneic CAR T-cell field. I personally couldn't be more excited about Cellectis' position in the market today with a healthy lineup of clinical programs that will deliver data and create value for all patients and stakeholders one after the other. It was a long road with many challenges to get where we are today, but we always successfully overcame every challenge in our way. This speaks for the expertise and resilience of our team. We are well capitalized to achieve our next milestone, and I'm excited for what is to come out for both our proprietary as well as licensed clinical programs together with our partners, Allogene and Servier. With that, I would like to open the call to address any question you may have. Operator, please go ahead. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) First question is from Jim Birchenough of Wells Fargo. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [2] -------------------------------------------------------------------------------- Congratulations on all the progress during the quarter. A couple of questions. I guess, first, just in terms of the alemtuzumab preconditioning, what's the earliest that we might be able to get a sense on whether that's the optimal approach to preconditioning? And if it turns out that it does become part of the standard of care for allogeneic CAR-T therapy, how could you leverage your IP around CD52 knockout outside of Cellectis? And then I've got a follow-up. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [3] -------------------------------------------------------------------------------- Thank you so much. Great question. This is Simon. I would like to direct this question to Carrie, because she is obviously heading the clinical operations. Carrie? -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [4] -------------------------------------------------------------------------------- Sure. Thanks for the question. So as we've previously said, we've submitted the amendment to FDA. We have to, obviously, get all that through at all the sites. We're hoping to have updates on our data, as we've already disclosed, hopefully by -- for one of the programs by the end of the year. And it will really all depend on how long it takes to get through all the process that is required for getting changes to protocols updated throughout our sites and through FDA. But I'm hopeful that we will have data in a reasonable short time frame to better understand that this is the appropriate way forward. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [5] -------------------------------------------------------------------------------- And second part of the question, that's a good point on the IP on CD52. So just as a reminder for everyone, we are the inventor and the patent holder of the CD52 knockout in CAR T-cells together with the concurrent administration of alemtuzumab, which is an antibody that is targeting CD52. So this, obviously, is becoming a very interesting patent and concept that we pioneered in 2015 and now becomes to -- it looks to become a real standard part of this prolonged persistence. And the question is, like there are some programs that may need prolonged persistence of CAR T-cells. In some other cases, you don't want to have that prolonged persistence. But maybe, André, you can add some comments on our strategy around this. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [6] -------------------------------------------------------------------------------- Jim, it's a very good question. And it is a very powerful tool for engrafting and expanding allogeneic CAR-Ts in general. But there are a few exceptions in there. For example, UCARTCS1, that is definitely in hold today, is cells lymphodepleting, CAR-T, that is supposed to have the same type of action similar to alemtuzumab. So for UCARTCS1, we don't precondition with alemtuzumab, and we expect the UCART to have similar activity in there. So all in all, I think this could become one of the standards, but there are other alternatives in there that could potentially also bring powerful approach into engrafting and the persistence of the CAR, yes. And the IP, of course, like it's an important component. And I think Cellectis has been for, now like 8 years in a row, building on this allogeneic approach and gene-edited CAR-T in general. And I think that we have like a strong IP estate in there that we definitely are willing to leverage and find the industry. Our goal is not to block those. We definitely try to enable great options we would like and treat on the medical need in general. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [7] -------------------------------------------------------------------------------- UCARTCS1 and the adverse patient outcome here, could you give us any more detail as to whether there were cytokine release syndrome associated with this patient? If -- and this might have related to the self-preconditioning of the product? Or if there are patient factors that could be easily excluded going forward? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [8] -------------------------------------------------------------------------------- Again, that'd be a good question for Carrie. And just upfront, Jim, we haven't disclosed any of the details yet because we're still collecting the data and all the information for that patient. But just as we noted, this patient death occurred very much towards the end of the DLT observation period, which is 28 days long. So Carrie, if you want to elaborate on that a little bit. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [9] -------------------------------------------------------------------------------- Yes, there's not that much additional to say. I think given that we are still gathering information and we haven't disclosed the details at this time. I don't want to further elaborate on it at this moment. But I think from what Simon just said, it was really towards the end of the DLT period. It's a complicated story, and we will -- once we're off-hold and we're moving forward and have a plan, we will be sharing this information. -------------------------------------------------------------------------------- Operator [10] -------------------------------------------------------------------------------- Our next question is from Michael Schmidt of Guggenheim. -------------------------------------------------------------------------------- Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [11] -------------------------------------------------------------------------------- Another question around the multiple myeloma program. You did mention that you decided to expand already at dose level 1 prior to the safety event occurring. Maybe talk a little bit about what gives you confidence that this is the right dose already at this point. And how do you think about the need to potentially explore further doses in the future? Maybe just a few more -- some more color around that item. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [12] -------------------------------------------------------------------------------- Yes. So maybe I can start and hand it over to Carrie. So for UCARTCS1, just as a reminder, we started at 1 million cells per kilogram as a dose. This was with the consideration that UCARTCS1 is also targeting a portion of the patient's T-cells expressing CS1, because the CAR-T itself has an edit to remove CS1 from the surface. So this kind of dual action of both targeting multiple myeloma cells and a portion of the patient's T-cells led us to initiating the study at a slightly higher dose than, for example, UCART123 or UCART22. And now, Carrie, maybe you can say a little bit of color on what we think the plan forward could be. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [13] -------------------------------------------------------------------------------- Yes. Sure. So thanks so much for that question. As Simon pointed out, so the dose at dose level 1 in this study was actually very close to some of the final doses for other CAR T-cells that are out there. So we're definitely starting at a higher dose. And as you know, we're collecting safety, activity, translational data as we go along through the dose escalation. So once we open dose level 2, we were starting to get additional data from the first dose level, and it just appeared that dose level 1 might -- now again, we didn't say for sure, because it's not -- it's early on in the development and it's still in the dose escalation phase. But it appeared that dose level 1 may have data that supports further expanding at that dose and potentially being the dose. It doesn't necessarily rule out expanding or -- and exploring other dose levels. But I think the data that we were getting from dose level 1 seemed to support that it was at least worth further pursuit at that dose level. -------------------------------------------------------------------------------- Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [14] -------------------------------------------------------------------------------- Just on the incorporation of alemtuzumab-based lymphodepletion into the other 2 trial product CARs, I was just wondering if you could provide some additional thoughts on some of the protocol amendments. Are you planning, for example, to evaluate several different doses of alemtuzumab repeat dosing? Or is it just going to be one cohort in each study that -- where you evaluate a certain fixed dose? Maybe talk a little bit about how you think about the various parameters that need to be evaluated to optimize the lymphodepletion protocol there. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [15] -------------------------------------------------------------------------------- Yes. I can take that, Simon. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [16] -------------------------------------------------------------------------------- Yes, Carrie, go ahead. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [17] -------------------------------------------------------------------------------- Okay. So thank you so much for the question. And again, these -- since we're in Phase I and we're exploring all of the above, so to speak, it's a work in progress. So I think that -- in my opinion, the important piece with alemtuzumab isn't necessarily the schedule per se and how -- when it's given, how often it's given, but it's really more about the -- balancing the deep selective T-cell depletion that you get with alemtuzumab with the safety. Because you're well aware and we -- the alemtuzumab data has been presented for many years in the context of allogeneic hematopoietic stem cell transplantation. There is definitely risks of viral infections, other opportunistic infections, et cetera. So the real key here is to give enough to get the selective T-cell depletion we need without over immuno-compromising the patients such that they can be at significant risk of these types of opportunistic infections, which then would defeat the purpose of what we're trying to do for their cancer. So that's the way I'm looking at it, and we will be exploring the use of it and looking for the optimal way forward. And obviously, that would include all of the above that you bring out. And I don't know if -- I don't think that you need to be trying multiple -- so many different ways of giving it. I mean you can, but I'm not sure if it's -- based on the data that already exists, if it makes that much of a difference. I think we have a good sense from not only the data from Allogene and Servier, but also from data previously with allogeneic stem cell transplantation of what an optimal dose is and how to give it safely, since there are significant risks in terms of infusion-related reactions and other things with alemtuzumab. So I think all of that data together will really help us pinpoint how to do it, so we can move quickly as opposed to having to try a million different ways of giving it. -------------------------------------------------------------------------------- Operator [18] -------------------------------------------------------------------------------- Next question is from Gena Wang of Barclays. -------------------------------------------------------------------------------- Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [19] -------------------------------------------------------------------------------- So regarding the UCARTCS1, just wondering, I know since the last announcement has been 1 month, did you have additional communication with FDA? And can you share a little bit more of what FDA is looking for? And when do you think you can submit the package to the FDA? And then second question is, later this year, 4Q, maybe hopefully at ASH, can you lay out the data we might see from all the programs, the UCART22, 123 and CS1? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [20] -------------------------------------------------------------------------------- Yes, Carrie, first question, and maybe André can chime in on the second question. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [21] -------------------------------------------------------------------------------- All right. Perfect. So I'll start. So Gena, thank you so much for your question. And we know that you and others want to know exactly what FDA wants us to do and how quickly we'll move forward. And at this time, I don't think we want to disclose exactly what is being requested. I think what's important to know is that we were in discussions with FDA. They're supportive. And we will be moving the program forward and ensuring with their help that we can do it in a smart, appropriate way to ensure patient safety, which is really the bottom line. So we will be working with them to come up with how we can best do that. That's really all I can say at this point, but I understand that you'd love to know more. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [22] -------------------------------------------------------------------------------- No worries. And André, maybe for the second part of the question, how we're building our momentum for data presentation towards the end of the year? -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [23] -------------------------------------------------------------------------------- Well, it's a great question, Gena. The idea is essentially -- like we have 3 trials. One, I hope we'll resume as soon as necessary actually for the FDA and us to be sure that we're going not to repeat the same type of event, hopefully. But we have 3 trials and interesting data to share, but we don't want to -- would like to keep the momentum in there. It's like out from the 3 trials, we'd like to start potentially at the end of this year releasing part of the data, as we always said. And then on a regular basis, scientific conferences organized by us, we will release regularly data from each trial and update you on the initial trials also, as we think that the development of this is starting without alemtuzumab and adding alemtuzumab with the same doses and comparing the 2 and advancing with, like, dose escalation up to the time we'll arrive into the expansion phases. And I think this would be starting at the end of this year, a very rich -- data-rich course for the company, and hopefully, potentially, other things that would come up such as like the kickoff of the manufacturing, the go-live for the manufacturing site in Paris, the go-live for the manufacturing site in Raleigh that I think are 2 very important events in transforming the company into a true biopharma and moving towards, I hope, for all the 3 trials, for the pivotal trial and potentially registration and commercializing this product. -------------------------------------------------------------------------------- Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [24] -------------------------------------------------------------------------------- Which program do you think that we will see the data first? -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [25] -------------------------------------------------------------------------------- So kind of the -- which trial, we're not saying that. Yes, it's definitely something that we know it, but we'd like to keep the suspense up to the end. But as we said, it's going to be very early data on -- like we started the trials at the beginning of this year or end of last year. It will be early, and it will be partial at this stage. But I think it's going to be interesting. -------------------------------------------------------------------------------- Operator [26] -------------------------------------------------------------------------------- Next question is from Biren Amin of Jefferies. -------------------------------------------------------------------------------- Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [27] -------------------------------------------------------------------------------- Maybe to start on CS1. For the first dose level, I believe investigators had activated the Rituxan switch. Can you just talk about the patients that received Rituxan in that first dose level and what caused the investigators to administer on that? And then, I guess, on the CD22 CAR, are you restricting patients that come in and that have received prior CD19 CAR based on their prior response to CD19 CAR? And then, I guess, for both the CD22 and the CD123 CARs, what -- are you testing different doses of alemtuzumab in those studies? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [28] -------------------------------------------------------------------------------- Yes. I'll hand it over to Carrie to answer these questions. Thank you, Biren. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [29] -------------------------------------------------------------------------------- Carrie, I guess, that you have to unmute yourself. We don't hear you. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [30] -------------------------------------------------------------------------------- Sorry about that. Thank you. Yes, thank you for the questions. At this time, we haven't disclosed details about the patients in the CS1, the UCARTCS1 study. We're gathering all of our information. We are evaluating what happened with the patient -- as I said earlier, with that patient. And we are -- will disclose and present this data when we have everything available so that we can be making smart decisions about moving forward as well as giving a full picture as to what happened with the study. So at this point, I'm really not going to disclose the details about the individual patients and their course. So that's the first part of the question. And the second part, I think, was about the alemtuzumab, if I'm remembering correctly. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [31] -------------------------------------------------------------------------------- Whether... -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [32] -------------------------------------------------------------------------------- Go ahead, yes. Please. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [33] -------------------------------------------------------------------------------- The second question was regarding the CD22 and whether patients -- you're enrolling patients based on the prior response of CD19 CAR. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [34] -------------------------------------------------------------------------------- Yes. So patients who've had prior CD19 CAR are allowed -- are eligible for the trial, and there have been patients enrolled. But it's not required for entering the study. -------------------------------------------------------------------------------- Operator [35] -------------------------------------------------------------------------------- Next question is from Yigal Nochomovitz of Citi. -------------------------------------------------------------------------------- Samantha Lynn Semenkow, Citigroup Inc., Research Division - Senior Associate [36] -------------------------------------------------------------------------------- This is Samantha for Yigal. Just a broad question just to start with. As you look over the recent ALLO-501 data and you think about correlation to your own program, what are the big takeaways from read-through from that data that you think applies to your pipeline? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [37] -------------------------------------------------------------------------------- Again, that's a good question for Carrie. Sorry, Carrie, I don't know about you? -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [38] -------------------------------------------------------------------------------- I don't know. It's a good question for anyone. So yes, thank you so much for the question. Again, we know that the UCART19 and ALLO-501 is the same construct with, obviously, a different CAR as our entire pipeline. And so I think all of the data and the positive momentum in that program reads through very nicely to our entire pipeline as well. And I think that it shows that and really validates our approach. It validates our gene editing. It evaluates -- it validates the constructs. And I think that we could read through significant important clinical as well as just programmatic data to move forward. I think that it's really terrific. And I think we can take a lot of that in terms of the safety, in terms of the conditioning, in terms of all of the above. So I think it's a really positive, important piece of our pipeline and our approach to CAR T-cells. I don't know if Simon or André have anything additional to add to that. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [39] -------------------------------------------------------------------------------- Things like for -- like it depends on the CAR-Ts. For example, 123 is totally different. And so it's like difficult to connect the 2 when the targets and the diseases are totally different. But when it's B-cell malignancies like 19 over 22, and like it's the same architecture for both CAR-Ts, so totally similar. So it's the same type of structure of the CAR. It's the same type of -- like there was a suicide switch in there, and it was removed for DLBCL, same type of knockouts that were made with the same molecule. And it's the same type of diseases, BLL and potentially DLBCL. So there is potentially some conclusion that some connections that can be made, and that's very fruitful to have already a CAR that is far more advanced and where we can tune out the way to do the things with that. So yes, I think the connections place when -- in the same indication for the same type of diseases. But when you go with the new targets, it's totally disconnected, I think, and then like it's totally new story that has to be told. And CD19, it remains very interesting, by the way. -------------------------------------------------------------------------------- Samantha Lynn Semenkow, Citigroup Inc., Research Division - Senior Associate [40] -------------------------------------------------------------------------------- Great. And that's very helpful, and it sort of leads into my next question as well. For UCART22, you're focused on B-ALL. But I'm curious if you thought of expanding into non-Hodgkin's lymphoma, given CD22 is also expressed in those tumors. And also, Allogene's early data suggests that retreatment of CD19 CAR-T might not be effective, but potentially a CD22 CAR-T could have better results. Just curious on your thoughts and opportunity. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [41] -------------------------------------------------------------------------------- Well, I can take this question, by the way. So thank you. So CD19 is an overcrowded target. You have everything against CD19, bispecs, CAR-Ts, autologous, allogeneic, et cetera. So the pressure on the target, a lot of patients, is high. Therefore, you have a lot of patients that relapse after CD19 overpressure. That's where we believe CD22 becomes an interesting product with a very high unmet medical need. Now it has to, of course, be efficient and provide benefit to the patient. But the overpressure around 19 that -- like named and there's like, I don't know, probably 80% of all the clinical trials on CAR-Ts are targeting 19 over the world and from Allogene to autologous to whatever other type of designs are all targeting the same thing, because it did work at a time. So that's why we think we're in an interesting spot here, because it triggers also a very high unmet medical need. Same thing for BCMA, by the way. -------------------------------------------------------------------------------- Operator [42] -------------------------------------------------------------------------------- Our next question is from Raju Prasad of William Blair. -------------------------------------------------------------------------------- Samantha Corwin, William Blair & Company L.L.C., Research Division - Associate [43] -------------------------------------------------------------------------------- This is Sami on for Raju. And jumping off a previous question about learnings from Allogene, since they're developing a next-generation ALLO-501A, without the rituximab safety switch, I was curious if you guys had any plans to produce a similar product, one of your either UCARTCS1 without a rituximab switch or UCART123 without a rituximab switch. If that was an idea you guys had kind of thrown around at all or if you're waiting to see the data Allogene produces? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [44] -------------------------------------------------------------------------------- Yes. Thank you for the great question. This is a very important part of our platform strategy, because we have all these tools at our disposal. So it's a very interesting position that at Cellectis we find us in, because we were really the first ones to go into allogeneic-CAR-T and think of all these parameters with an off switch, with CD52 knockout for alemtuzumab, co-injection with different type of gene edits. So it's really kind of turning out to be a very enviable position that we're in, because we have the ability to use all these tools at our disposal. So Allogene, as you know, has triggered a larger upfront milestone payment to us with the demand of basically having an ALLO-501A version without the rituximab off switch. And from their perspective, this was to actually include patients in NHL that have been treated with rituximab in their course of therapy, so to not exclude these patients if that antibody is still present in their system. This is something we could do at any time. We haven't disclosed any program where we would do this at, but just consider that all options are always on the table for us. -------------------------------------------------------------------------------- Operator [45] -------------------------------------------------------------------------------- The next question is from Wangzhi Li of Ladenburg Thalmann. -------------------------------------------------------------------------------- Wangzhi Li, Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology [46] -------------------------------------------------------------------------------- So maybe to start with a follow-up on the UCARTCS1 patient. I know you cannot share too much. But just curious, do you know if the patient had preexisting cardiovascular conditions or risks? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [47] -------------------------------------------------------------------------------- Thanks, Wangzhi, for the great question. And again, I'm sure Carrie's answer will be the same that we haven't disclosed more information on this patient. But Carrie, if you want to add anything, please go ahead. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [48] -------------------------------------------------------------------------------- Yes -- no. I really appreciate the question, and I know everybody wants to know, but we really would like to wait and compile all of the data to present the story in a cogent, consistent manner once everything is together as opposed to a little bit here and there. But thank you. -------------------------------------------------------------------------------- Wangzhi Li, Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology [49] -------------------------------------------------------------------------------- Okay. I can understand. So -- but any color if the autopsy -- what's the status of autopsy analysis? It's been done, or is it in the process? Or just any sense on the time line? -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [50] -------------------------------------------------------------------------------- Yes. Again, I don't want to comment on what information and additional data and clinical information we're going to receive and when. But again, once we have everything together and we're able to present it all to FDA and have a plan forward, we will work on getting that information presented. -------------------------------------------------------------------------------- Operator [51] -------------------------------------------------------------------------------- The next question is from the Salveen Richter of Goldman Sachs. -------------------------------------------------------------------------------- Salveen Jaswal Richter, Goldman Sachs Group, Inc., Research Division - VP [52] -------------------------------------------------------------------------------- So just kind of a follow-up here on the CD19 population for UCART22. But in the Allogene study, when they looked at refractory autologous CAR-T patients, they didn't really have a response or they may have had resistance here. Just curious in your thoughts there as you look to this population, if there's any way to kind of adapt from those learnings. And then a second question on Calyxt. Is there a strategy change here with the focus on kind of optimizing TALEN-based technology? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [53] -------------------------------------------------------------------------------- It's Simon. Thank you so much for all the good questions. I will maybe first address Calyxt and then talk about your first question on CAR-T-naïve versus pretreated. So Calyxt is just evolving in their business, as they have always pursued a strategy of monetizing the TALEN technology. The company is really a fantastic brain pool to address challenges through gene editing in the ag field that traditional companies just don't have the tool set for. So there's more and more demand for projects that other companies would like us to work on. And the company is also pursuing a very lean business model to have -- first of all, the proof-of-concept with the soybean was made to show we can develop a product, bring it into the market and commercialize it. It's a great product. There's demand for it. But there's a lot of work attached to kind of having this downstream integration. But this was to show we can get into 100,000 acres and really build a huge business around this with railroad, car access, with crusher access for the soybeans, et cetera. So that was fantastic work done by the team in record time, given they're the first company in the world that actually commercialized the gene-edited agriculture food product. Now the transition is more into an asset-light business model to not do it yourself, so to speak, with establishing that infrastructure, but working with partners to build products together for kind of like in the biotech industry for upfront and milestone fees. So for the question on CAR-T, so it's interesting because Allogene mentioned on their earnings call that they're exploring retreatment of patients. They have seen that patients that, for example, are partial responders in an initial shot are getting retreated or will potentially be retreated. So we're super-excited for that part of the strategy to become more prominent, because we think the allogeneic concept is positioned to be this way, that you have an off-the-shelf drug that you can dose and where you can do repeat dosing. So that's very exciting. We saw the first data from that actually already a couple of years ago where a handful of patients were retreated successfully. So we're looking forward to what Allogene is working on and will be presenting in the future. We think about that type of strategy as well. But in terms of patients that have been treated with autologous CAR-T, as André said, there's a lot of pressure on the CD19 antigen with a prior CAR-T treatment, whether it's autologous or allogeneic. And that's why we pursue this dual strategy of being first in the pack of an allogeneic CAR T-cell set of companies pursuing very prominent targets with CD19 and BCMA, for example, and these are our license programs. And then the proprietary program at Cellectis are with alternative targets that could address patients that have not responded or basically relapsed without the expression of any given antigen. And Carrie, if you want to elaborate on that further. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [54] -------------------------------------------------------------------------------- Yes. I mean I think the question regarding the fact that in the Allogene data that was presented that the patients who had prior CAR-T did not seem to have the responses. The other one is, I think we have to look at the targets as -- to point, Simon. And so in that case, it's the same target. So those are in NHL. The auto CAR-Ts are also CD19. So it sort of follows. And even though we're -- they're going with an allogeneic product, it's still the same target. So it's not unexpected that they were less likely to respond to another T-cell therapy with the CD19. And I think our approach -- in our case, it's a different target. So even if somebody had received, whether it be an allogeneic product with CD19 that's already been -- that's in clinical trials, like Allogene, like our UCART19, or if it's in auto 19, I don't believe that the fact that we're pursuing a different target, I don't think it reads through to seeing or being an issue in terms of response. -------------------------------------------------------------------------------- Operator [55] -------------------------------------------------------------------------------- The next question is from Hartaj Singh of Oppenheimer & Co. -------------------------------------------------------------------------------- Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [56] -------------------------------------------------------------------------------- I just had a question on manufacturing. I know that you've indicated on the prepared remarks that the manufacturing should be up and running by the middle part of next year, both in Paris and Raleigh. Now if you can just kind of walk us through where exactly are you with the 3 projects. Is this sort of clinical-grade material? And at some point, as you move to larger clinical trials next year, you will transition to commercial-grade material? I mean FDA has indicated that this is one of the really big rate-limiting steps for most cell therapies. And it seems like you're close to potentially solving it. So could you just walk us through your -- how you see that transition happening for these 3 projects, assuming they move on to larger pivotal trials with clinical to commercial manufacturing? And I've just got a quick follow-up. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [57] -------------------------------------------------------------------------------- Yes. Thanks. That's a great question, Hartaj. And this is kind of the basis of what we're doing is really differentiating ourselves with a rich pipeline of different programs and that are all going to be manufactured in-house. So this transition... -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [58] -------------------------------------------------------------------------------- I can... -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [59] -------------------------------------------------------------------------------- Yes, André, you can go ahead. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [60] -------------------------------------------------------------------------------- Simon, maybe I can answer very simply the question to Hartaj, because like the answer is very simple. We are not starting by having the grading of the production at our manufacturing plants, clinical supplies first and then upgrade it to commercial. We already start as if we're producing the pivotal and commercial CAR-T. And the grade will be commercial at start, but it will produce also our clinical supply. So it will be already totally fully GMP and like the inspection, et cetera. So we're -- it's not done in 2 steps. It's a one full step for commercial, and then it will be producing clinical supply there. -------------------------------------------------------------------------------- Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [61] -------------------------------------------------------------------------------- Great. André, that's very helpful. And then -- so it seems like the -- as you go to larger trials and potentially pivotal trials, any one of these 3 projects, you should -- the CMC part of future application is sort of already kind of mostly locked into place? -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [62] -------------------------------------------------------------------------------- Actually, can you rephrase your question? I'm not sure I understood. -------------------------------------------------------------------------------- Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [63] -------------------------------------------------------------------------------- Yes. So I apologize. Yes. So assuming a future New Drug Application, NDA, for any 1 of the 3 projects, CMC is one of the 3 sections, right, preclinical, clinical and CMC. Is it a good assumption on our part that moving forward, your CMC portion of a potential future NDA is already sort of mostly -- as a company, you have great visibility into that in terms of that section of a potential NDA following with the FDA? -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [64] -------------------------------------------------------------------------------- Well, yes, exactly. Like the goal is to start putting all the procedures internally to fulfill this, like, CMC section for the FDA. That's the plan, frankly. And we're preparing the company to -- because we don't know how these trials will go. But you always plan for success, and that's what we're doing. If it's successful and the CAR-Ts are -- give promising results, especially, for example, in AML or on ALL and there is like a very strong medical need in there and it can go pretty fast, so it's better to be ready ahead of time and not to do it in like several steps. And so that's like the target is definitely in the BLA at the end. And that's what we have in view in there only. -------------------------------------------------------------------------------- Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [65] -------------------------------------------------------------------------------- Great. André, that's very helpful. And I think that's very forward-looking. Another question is -- and you might have addressed this in your prepared remarks, so I apologize, I just got a little late. But you've managed to bring basically one product to the clinic over the last 3 years. You've got 3 in the clinic right now. And I know you've got a lot on your hands in all 3. But what are your thoughts in terms of bringing more projects into the clinic? Are you still hoping to keep to that one project per year into the clinic goal? Or you think that the next 1 or 2 could take maybe just a little bit longer? -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [66] -------------------------------------------------------------------------------- It's an excellent question, because we needed to ramp up our clinical capacity and production capacity, because the space is becoming overcrowded. So like name it, like gene therapy, like retroviral vectors, gene editing, cell therapy and immuno-oncology, you said all the buzzwords in the space and like everyone jumping in there. So the goal we have, the strategy we have is like to target term of INDs up to the time we ramp up in term of capacity for production will be fully fledged next year with the Raleigh side going live and Paris side going live this year. We'll be producing like nucleic acids and vectors and also ramping up, since the arrival of Carrie, that's totally transforming all the clinical department in the company and ramping up also the department to large capacity. I give you rendezvous for, I hope, like in 2021, at an R&D Day, we will unveil all the thing that makes Cellectis so much distinctive than most of other companies. Our innovation department, that is very, very productive. Like you can see through most of the publications. But we decided to paint this down in terms of communication for now, and we hope once there will be releasing the pressure over the clinical data and started releasing the data by the end of this year, we'll have maybe an appointment and like a nice R&D. They will be able to show what is the power of this pipeline behind it and start releasing new INDs at this time. And I think that's going to be a very exciting time, because I'm very proud of our R&D department that I think is one of the most innovative of all the cell therapy and gene therapy space. -------------------------------------------------------------------------------- Operator [67] -------------------------------------------------------------------------------- Our last question is from Madhu Kumar of Baird. -------------------------------------------------------------------------------- Unidentified Analyst, [68] -------------------------------------------------------------------------------- [Rob] on here for Madhu. I was just wondering, how do you think you can use your candidates post CAR-T and if there are any specific safety concerns? -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [69] -------------------------------------------------------------------------------- Carrie, would you like to start with that? -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [70] -------------------------------------------------------------------------------- Sure. Just -- can you just clarify again what your -- the question? I'm sorry. It wasn't quite clear. -------------------------------------------------------------------------------- Unidentified Analyst, [71] -------------------------------------------------------------------------------- Sure. I was just wondering, how do you think about the use of your candidates post auto CAR-T? And are there any specific safety concerns? -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [72] -------------------------------------------------------------------------------- Sure. I don't see there being an issue using them post auto CAR-T at all. I think that, obviously, we're always in Phase I and, in early studies, looking at safety. Obviously, when someone's been previously treated with an auto CAR-T, they've received similar lymphodepletion prior to those products. So from that perspective, you may want to look a little bit closer at that. But from the perspective, by the time they would be progressing from their prior therapy and getting to our study, there wouldn't be necessarily auto CAR-T around anymore. They wouldn't have been progressing. So I don't see there being any real concern with those patients versus patients who hadn't received a prior auto CAR-T. But obviously, it's an area of -- a new area that needs to be focused on and pay attention to. But I don't foresee any specific issue that I would be concerned about. -------------------------------------------------------------------------------- Operator [73] -------------------------------------------------------------------------------- That concludes our question-and-answer session. Thank you. I would like to hand the call back to Simon for closing comments. -------------------------------------------------------------------------------- Simon Harnest, Cellectis S.A. - VP of Corporate Strategy & Finance [74] -------------------------------------------------------------------------------- Yes. Again, thank you all very much for all these great questions and your patience in getting through the Q&A. We always love to hear your feedback. So feel free to call me or any one of our team for follow-up discussions. And we're super-excited for the second half of this year. Everything in the clinic is moving forward, and it will be a very data-rich second half and next 12 to 18 months. Thank you. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [75] -------------------------------------------------------------------------------- Thank you, everyone. -------------------------------------------------------------------------------- Carrie Brownstein, Cellectis S.A. - Chief Medical Officer [76] -------------------------------------------------------------------------------- Thank you so much. Take care. -------------------------------------------------------------------------------- André Choulika, Cellectis S.A. - Co-Founder, Chairman & CEO [77] -------------------------------------------------------------------------------- Thank you. -------------------------------------------------------------------------------- Operator [78] -------------------------------------------------------------------------------- This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.